Rofecoxib (Vioxx®, Merck) works as well as naproxen (e.g., Drug Naprosyn®, Roche) at controlling the symptoms of osteoarthritis and is also effective at a much lower dose and with less severe adverse gastrointestinal (GI) effects. The ADVANTAGE (Assessment of Differences between Vioxx And Naproxen To Ascertain Gastrointestinal tolerability and Effectiveness) Study Group compared the use of rofecoxib 25 mg/day with that of naproxen 500 mg twice daily in 5,557 older patients with osteoarthritis. This is thought to be the largest trial to compare GI symptoms that prompt patients to discontinue treatment.

Overall, a statistically significant lower number of patients stopped taking rofecoxib (5.9%) because of GI adverse drug events (ADEs) compared with the naproxen group (8.1%). A similar risk of ending treatment was noted among subgroups of patients using low-dose aspirin and among those who had previously ceased to use their arthritis medication because of GI symptoms. Improved GI tolerability was confirmed by the decreased use of gastroprotective medications and by a reduced incidence of serious GI events, such as perforations, ulcers, and bleeding. No significant differences were observed in general, cardiovascular, or hypertension-related ADEs.

The FDA has granted a Premarket Approval Application (PMA) for 1% sodium hyaluronate (Nuflexxa™, Savi-ent Pharmaceuticals, Inc.).

Nuflexxa™ is indicated for the treatment of pain in osteoarthritis of the knee in patients who have not responded adequately to conservative nonpharmaco-logical therapy or simple analgesics . The product has been approved in Europe as Euflexxa™.
canadian pharmacy support net

This is the only non-avian-derived hyaluronic acid approved in the U.S. It is a product of Bio-Technology General (Israel) Ltd., a Savient subsidiary.

Genzyme Corporation has received European approval to expand the CE Mark labeling for hylan G-F 20 (Synvisc) to include the treatment of pain resulting from osteoarthritis (OA) of the ankle and shoulder. The CE Mark is mandatory for 70% of the products sold in Europe.

Synvisc is sold in more than 60 countries and is approved in the U.S. to treat pain resulting from OA of the knee. The approval of the new indication was based on prospective, multicenter, open investigations in Europe. Treatment with one or two injections was well tolerated.
canadian pharmacy viagra

As a nonsystemic treatment, Synvisc helps avoid some of the side effects associated with some nonsteroidal anti-inflammatory drugs (NSAIDs), including cyclooxygenase-2 (COX-2) inhibitors.

Genzyme is pursuing a label expansion in the U.S. that would include an indication for the hip.

Diclofenac sodium topical gel 1% (Voltaren Gel, Novartis) has been approved as the first topical prescription treatment that patients can apply directly to sites of pain associated with osteoarthritis, a condition in which the cartilage in the joint breaks down.

Voltaren Gel is a nonsteroidal anti-inflammatory drug (NSAID) that can be used to treat pain associated with osteoarthritis in joints amenable to topical treatment (e.g., the knees and hands).

Read the rest of this entry »